Z-0003-2022Class II

Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number...

Name: Z-0003-2022 Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number...
Creator: Medtronic Perfusion Systems
Published: 2021-09-13
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2021-09-13 / Open, Classified / root cause: labeling and UDI

FDA source

Medtronic Perfusion Systems began a recall of Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile on 2021-09-13. FDA classified it as Class II and gives the reason as "There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0003-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-13
Posted: 2021-10-01
Recalling firm: Medtronic Perfusion Systems
Product: Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The recalling firm issued letters dated September 2021 beginning 9/13/2021 via 2-day UPS delivery to consignees. For outside of the United States, the recall letter will be delivered via regionally-approved methods to consignees who received the product. The letter explains the issue and requests the consignee review their inventory for the affected product. The product is to be immediately quarantined and returned after first contacting Customer Service. A Customer Confirmation Form was enclosed to be returned via email. The letter was to be shared with others within their organization as appropriate and to any other locations who have received the product through a transfer. Consignees are asked to review the Medtronic Urgent Medical Device Recall notification and follow the Recommended Actions, including quarantining and returning all unused affected Bio-Medicus Insertion Kits in their inventory.
Quantity in commerce: 168 kits
Distribution: Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey.
Product codes and lots: Model 96553 - Serial number 220719040, GTIN 20763000116006; Model 96551 - Serial number 220641720, GTIN 20763000115986.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0003-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0003-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-13	2021-10-01

Product code DWF

K190557Class IIBio-Medicus Insertion KitMedtronic, Inc. / cleared 2019-04-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)